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DATA SHEET XALATAN® Eye Drops (Latanoprost 50 Micrograms/Ml)

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DATA SHEET XALATAN® Eye Drops (Latanoprost 50 Micrograms/Ml) DATA SHEET XALATAN® Eye Drops (Latanoprost 50 micrograms/mL) NAME OF THE MEDICINE The chemical name of latanoprost is Isopropyl-(Z)-7[(1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3- hydroxy-5-phenyl-1-pentyl]cyclopentyl]-5-heptenoate, according to IUPAC. Its molecular formula is C26H40O5 and its molecular weight is 432.58. The CAS number for latanoprost is 130209-82-4. The structural formula is as follows: OH COOCH(CH3)2 OH OH DESCRIPTION The active ingredient in XALATAN is latanoprost, a prostaglandin F2α analogue. Latanoprost is a viscous oil which is practically insoluble in water, freely soluble in ethanol, ethyl acetate, isopropanol, methanol, acetone and octanol, and very soluble in acetonitrile. Sixty four isomers of latanoprost are possible, however, for XALATAN it is purified as a single isomer. XALATAN Eye Drops is a sterile, isotonic solution containing 50 micrograms/mL of latanoprost in an aqueous buffer solution of pH 6.7. The excipients in XALATAN are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, Water for Injections and benzalkonium chloride (0.20 mg/mL) as a preservative agent. The solution is a clear and colourless liquid, filled in a polyethylene container. PHARMACOLOGY Pharmacodynamics Latanoprost, a selective prostaglandin F2α analogue, is a selective prostanoid FP receptor agonist which reduces the intraocular pressure (IOP) by increasing the outflow of aqueous humour. Reduction of the IOP in man starts about three to four hours after administration and maximum effect is reached after 8 to 12 hours. Pressure reduction is maintained for at least 24 hours. Studies in animals and man indicate that the main mechanism of action is increased uveoscleral outflow, although some increase in outflow facility (decrease in outflow resistance) has been reported in man. Clinical trials have shown that latanoprost has no significant effect on the production of aqueous humour. Latanoprost has not been found to have any effect on the blood-aqueous barrier. Version: pfdxalae10416 Supersedes: pfdxalae11113 Page 1 of 10 Latanoprost has no or negligible effects on the intraocular blood circulation when used at the human clinical dose, as studied in monkeys. However, mild to moderate conjunctival or episcleral hyperaemia may occur during topical treatment. Chronic treatment with latanoprost in monkey eyes which had undergone extracapsular lens extraction did not affect the retinal blood vessels as determined by fluorescein angiography. Latanoprost has not induced fluorescein leakage in the posterior segment of pseudophakic human eyes during short term treatment. Latanoprost in clinical doses has not been found to have any significant pharmacological effects on the cardiovascular or respiratory systems. Pharmacokinetics Latanoprost is an isopropyl ester pro drug which is inactive, but after hydrolysis to the acid of latanoprost, becomes biologically active. The pro drug is well absorbed through the cornea and all the drug that enters the aqueous humour is hydrolysed during the passage through the cornea. Studies in man indicate that the peak concentration in the aqueous humour is reached about two hours after topical administration. After topical application in monkeys latanoprost is distributed primarily in the anterior segment, the conjunctivae and the eye lids. Only minute quantities of the drug reach the posterior segment. Following an ocular dose of latanoprost, 45% of latanoprost acid is absorbed systemically, with 90% being bound to plasma proteins. There is practically no metabolism of the acid of latanoprost in the eye. The main metabolism occurs in the liver. Following intravenous administration in man, the half life in plasma is 17 minutes. The main metabolites, the 1,2-dinor and 1, 2, 3, 4- tetranor metabolites, exert no or only weak biological activity in animal studies and are excreted primarily in the urine. CLINICAL TRIALS Efficacy In three pivotal, randomised, double blind, parallel group trials latanoprost 50 µg/mL once a day was compared with timolol 5 mg/mL twice a day. Across the three trials, 460 patients received latanoprost and 369 received timolol. At 6 months latanoprost reduced IOP by 27 - 34% from the untreated baseline of 24.4 - 25.2 mmHg and timolol reduced IOP by 20 - 33% from a baseline of 24.1 - 25.4 mmHg. In one of these three studies, the difference between the reduction in IOP by latanoprost versus timolol was statistically significant (p < 0.001). A meta-analysis of the three trials demonstrated that of the intention-to-treat population, 61% of latanoprost treated patients, compared with 40% of timolol treated patients, reached a 30% reduction in diurnal IOP after 6 months. No tolerance to the effect of latanoprost was seen after 12 months in these trials. The pivotal studies have demonstrated that XALATAN is effective as monotherapy. In addition, XALATAN is effective as adjunctive therapy in reduction of IOP. Short term (1 or 2 week) studies suggest the effect of latanoprost is additive in combination with adrenergic agonists (dipivefrine Version: pfdxalae10416 Supersedes: pfdxalae11113 Page 2 of 10 hydrochloride), carbonic anhydrase inhibitors (acetazolamide) and at least partly additive with cholinergic agonists (pilocarpine). Although intended primarily as a safety study, IOP reduction was effectively maintained over 48 months in a clinical trial of 356 patients receiving latanoprost as adjunctive therapy to various medications including β-adrenergic antagonists, adrenergic agonists, cholinergic agonists and carbonic anhydrase inhibitors. Out of 519 patients at study start, only 7 patients were withdrawn from the study due to uncontrolled IOP. Clinical trials involving a fixed combination of latanoprost 50 µg/mL and timolol 5 mg/mL given once daily have also been conducted. The mean diurnal IOP-lowering effect of the combination was greater than that produced by monotherapy with either latanoprost 50 µg/mL once daily or timolol 5 mg/mL twice daily. Safety Long term safety of latanoprost has been investigated in an open label, multicentre, safety study. This trial enrolled 519 patients, 356 of whom continued for 48 months. Iris pigmentation changes have been observed in patients of the pivotal clinical trials of latanoprost (see also PRECAUTIONS and ADVERSE EFFECTS). The long term safety study has shown that this change is not associated with any increased risk of clinically significant ocular or systemic effects, nor is it considered to have any long term consequences. In those patients experiencing colour change, the time to onset of increased iris pigmentation usually occurred within 8 months of starting treatment. Within 24 months, onset had occurred in almost all of these cases. Onset after 36 months of treatment was very rare. Using iris photography, the increase in iris pigmentation was graded as “weak” in 75 out of 124 patients (60.5%) during the first year of onset. A weak grading was maintained in 42 of these patients (33.9%) over 48 months of treatment. In those patients showing iris pigmentation progression, there was no apparent increase in iris pigmentation during the fourth year of treatment, indicating a plateau in pigmentation had been reached. A separate safety study has also shown that reintroduction of latanoprost to patients with increased iris pigmentation will not necessarily lead to a further increase in iris pigmentation severity. IOP reduction between patients who developed iris pigmentation, and those who did not, was shown to be comparable over 48 months. Table 1 below shows the mean IOP and change from baseline in patients experiencing increased iris pigmentation (IIP) and those not experiencing increased iris pigmentation (NIIP). Version: pfdxalae10416 Supersedes: pfdxalae11113 Page 3 of 10 Table 1: IOP (mmHg) and change from baseline to 36 and 48 months’ visits in relation to the absence (NIIP) or presence of increased iris pigmentation (IIP) Baseline Month 36 Month 48 IOP IOP ∆ IOP IOP ∆ IOP NIIP Mean 23.7 17.6 -6.1 18.2 -5.6 SD 4.7 3.8 4.2 4.4 4.7 n 263 263 263 246 246 IIP Mean 23.9 17.2 -6.7 17.3 -6.5 SD 3.9 3.5 4.2 3.6 4.9 n 117 117 117 110 110 All Mean 23.8 17.5 -6.3 17.9 -5.9 SD 4.4 3.7 4.2 4.2 4.8 n 380 380 380 356 356 INDICATIONS Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. CONTRAINDICATIONS Known hypersensitivity to latanoprost or any of the excipients in XALATAN. PRECAUTIONS XALATAN may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in heterochromia. This change in eye colour has predominantly been seen in patients with mixed colour irides i.e., blue-brown, grey-brown, green-brown or yellow-brown. The highest incidence was found in patients with green-brown and yellow-brown irides. In patients with homogeneously blue eyes, no change has been observed and in patients with homogenously grey, green or brown eyes, the change has only rarely been seen. The onset of the change is usually within the first eight months of treatment, but may occur later in a small number of patients (see CLINICAL TRIALS). The colour change is due to increased melanin content in the stromal melanocytes of the iris and not to an increase in the number of melanocytes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish. Patients who develop increased iris pigmentation should be examined regularly and, depending on the clinical situation, treatment may be stopped. No further increase in brown iris pigment has been observed after discontinuation of treatment, but the resultant colour change may be permanent.
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